• Team leader for Regulatory Affairs operational excellence group supporting multiple businesses and medical products for global registrations and supply continuity efforts impacted by changing regulations worldwide (i.e., MDR, UKCA). • Provides regulatory management for new product development by providing early guidance and approval of regulatory strategy, labeling and promotional material for global clearance.• Authors and submits Investigational Device Exemptions (IDE), 510(k), Q-Submissions, technical dossiers and STED documents to support US, EU and global submissions.• Manages communications and negotiates with regulatory agencies on behalf of the business, as they pertain to regulatory decisions and strategies. • Leads notifiable changes and supplemental dossiers to appropriate regulatory authorities.• Ensures consistency of messages delivered via advertising and promotion materials in all forms (brochures, labeling, websites, social media, mobile applications etc.), as well as for sales training.• Escalates and effectively communicates issues to senior leadership.• Evaluates, develops, and implements procedures and processes to support regulatory activities.• Responsible for the development and leadership of long-term goals (resourcing, effective growth development of direct reports).

Regulatory Affairs support for over 15,000 open surgical and laparoscopic (including electrosurgical) devices, and sterilization containers spanning 5 facilities and multiple suppliers and manufacturers.• Authors and submits premarket notification 510(k) submissions to various CDRH branches including General and Plastic Surgery, Obstetrics and Gynecology, and General Hospital, and serves as the primary point of contact for FDA on U.S. submissions.• Obtained FDA clearance of six 510(k) premarket notifications within the FDA’s clock of 90 days. • Reviews and determines whether modifications to existing devices require new/revised documentation.• Reviews and approves all labeling for domestic and international compliance. • Approves all communications to trade publications, news media release, sales presentations and technical bulletins and analyzes the supporting data for claims verification. • Serves as RA leader on cross functional project teams. Sets submission timelines and establishes expectations with team members.• Provides continuing regulatory education and dissemination of regulatory information to the operations, development, marketing and manufacturing groups.• Actively participates on AdvaMed working group for Unique Device Identification (UDI).• Coaches and trains direct report on regulatory affairs activities.• Supports periodic inspections performed by FDA and other regulatory authorities.• Created and maintained technical file documentation to support CE marking of devices.

• Managed complex worldwide product change process for existing products, established a plan and prepared deliverables for submissions. • Compiled and submitted regulatory documents to Latin American, Asian, and Middle Eastern Baxter subsidiaries by creating a core dossier to support file submissions worldwide.• Strong knowledge of Brazil, China, Mexico and Singapore medical device regulations.• Reviewed and assessed impact of product / process changes (including labeling) for products marketed in international countries.• Responsible for managing the format and content of Premarket Notification 510(k)s• Provided guidance and coaching for areas of responsibility and assistance to lower level team members. • Lead or represented Regulatory Affairs and provided regulatory advice to project teams.

• Compiled and submitted regulatory documents according to international regulatory requirements for new product registrations and renewal registrations.• Responded to regulatory authorities’ questions within strict deadlines.• Prepared Global Regulatory Strategies for regions of responsibility.• Provided regulatory advice to project teams.• Reviewed and assessed impact of product / process changes for products marketed in international countries.

Authored validation protocols and analyzed/summarized data into validation reports.Created and modified Standard Operating Procedures.

Food and Drug Administration (FDA) Pre-Market Approval and General Inspection Support..Provided pre-inspection support (laboratory audits) and staging room support focusing on validation, non-conformances and Corrective Action / Preventive Action documentation.

Facilitated multiple Cross Functional Teams (CFT) on the compliant use of Corrective/Preventive action procedures.Utilized Six Sigma processes for investigations and Corrective/Preventive actions.Participated on a team to reduce the number of non-conformances in the Operational Quality Assurance organization.Developed process improvements to increase efficiency of Corrective/Preventative action procedure.Improved the effectiveness of the Corrective/Preventive action quality system by authoring change requests.

Supported the manufacture of retrovirus diagnostic assays by maintaining the technical integrity of the assays and their components.Collected and analyzed data; prepared supplemental reports to the FDA by coordinating efforts with various quality organizations and regulatory personnel.Created validation amendment reports to assure proposed changes would be compliant with validation.Revised quality controlled testing documents to improve efficiency resulting in increased production of diagnostic assays.

Supported all stages of validation of test methods for Retrovirus products including design of experiments, qualification of laboratory equipment, laboratory testing, and analysis and summary of data.Lead scientist for the remediation of Anti-Delta Enzyme Immunoassay (EIA). Responsible for the design of experiments and development of protocols for the validation of test methods used in the manufacture and release of product.Authored reports to provide objective evidence that essential control points in the manufacture of the HIVAG EIA products comply with FDA regulations for GMP. Coordinated with multiple quality groups and functional areas to assure that guidelines used to remediate various Abbott products met FDA requirements.